Depuis 2011 et les premières accréditations ISO 17025 et ISO 17020, HeX peut se prévaloir en janvier 2020, d’être en possession du scope d’essais dans le domaine de la salle propre le plus étendu d’Europe avec quasi 40 essais spécialisés et accrédités ISO 17025.
Alors que le groupe HeX renouvelle ses accréditations en janvier 2020 pour 5 années, la perte de confiance envers l’autorité compétente BELAC grandit et conduit HeX à annoncer publiquement en date du 20 juin 2020, le renoncement volontaire de ses accréditations prenant effet au 1er janvier 2021.
Ever since HeX started out, the ISO 17000 standards have formed the foundations of its management system, in particular ISO 17025 for testing, sampling and calibration laboratories.
After a decade of accreditations, HeX withdrew from the system and has confirmed its compliance with ISO 17025 across a scope of 40 tests.
The construction of the new laboratory at HeX LAB in October 2020, with its fully connected state-of-the-art facilities and technology, in terms of matrices associated with drugs, gave another boost to the HeX Group’s journey towards GMP/BPF standards for the pharmaceutical industry.
HeX: an ongoing commitment to quality
Since January 2021, HeX has been working hard to fulfil the euGMP requirements in order to welcome an inspection from the Federal Agency for Medicines and Health Products (Belgium) in June 2021.
8 October 2021
HeX GROUP
is officially recognised for its compliance with GMP
and in particular for quality control for drugs products.
This recognition fits in with HeX’s commitment to guaranteeing high quality for its clients. In addition, these GMP requirements also fit in with the continuity expected by HeX clients, whether they are in industry, biotech or hospital services, when it comes to fulfilling the same GMP requirements as they have to meet.
Scope of GMP
– Sterility tests – European Pharmacopoeia, chapter 2.6.1
– Microbiological control of non-sterile products : Microbial enumeration tests – European Pharmacopoeia, chapter 2.6.12
– Microbiological control of non-sterile products : Test for specified micro-organisms – European Pharmacopoeia, chapter 2.6.13
– Bacterial endotoxin test – European Pharmacopoeia, champter 2.6.14
Thank you everybody!
HeX GROUP and all of its employees are proud to continue in their quest for quality
whilst also building real partnerships with its clients, with a view to achieving a win-win relationship for everybody.
Would you like more information about our GMP approval and/or our quality management system?
